Harmonization Study guides, Class notes & Summaries

Chapter 1—Financial Reporting MULTIPLE CHOICE 1. The following is NOT a major component of the financial statements: a. auditor’s opinion b. annual report c. explanatory notes d. balance sheet ANS: B PTS: 1 TOP: AICPA FN-Reporting DIF: Easy OBJ: LO 1 MSC: AACSB Reflective Thinking 2. The following are users of accounting information: a. stakeholders b. creditors c. investors d. all of the above ANS: D PTS: 1 TOP: AICPA FN-Reporting 3. Interested parties receive information ab...

RAC Devices Exam Prep 2023/2024 (EU) Rated A+ Who is the European Medicines Agency (EMA) an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. The primary reason for establishing EMA was to harmonise the work being done by the individual regulatory bodies in Europe. Relevance of EMA in EU founded in 1995, working across the EU to protect human and animal health by assessing medicines to rigorous scientific standards and by providing partners and...

What is the importance of the Treaty of Rome (1957) on the Data Protection Directive and the GDPR? - ANS - Allowed the Data Protection Directive and GDPR to be setup as harmonization for European member states. How many member states in the European Union? - ANS - 28 member states What is the European Economic Area composed of? - ANS - EU member states + Iceland + Liechtenstien + Norway What are the key characteristics of the Data Protection Directive? - ANS - - Places obligations on memb...

Belmont Report was created as part of? Correct Answer: The national Research Act of 1974. Who was the Belmont Report formulated by? Correct Answer: The National Commission for the protection of human subjects in biomedical and behavioral research. What year was the publication of the FDA regulations made? Correct Answer: 1980 *1981 for the HHS and revised FDA Regulations. What year was GCP and HIPAA created? Correct Answer: 1996 What is the National Research Act? Correct Answer: ...

My prior role as chief architect of a global financial services organization placed me in the middle of several major transformation programs. A major goal of those programs was to speed up software delivery without compromising quality or security, two aspects that were believed to be at odds with each other. Undeterred by existing beliefs, we set out to deploy something called Agile Delivery Platform, which made software delivery “fast and compliant” and placed the broader IT organiz...

When did harmonization of regulations began? correct answers1980s Where and when was the birth of ICH? correct answersApril 1990 in Belgium What was the goal of ICH? correct answersUniform drug development standards and license application requirements Name of countries ICH covers drug development. correct answersUS, EU, Japan What happened during the birth of ICH? correct answersICH guidelines were published CTD specifications part of the guidelines ICH vs FDA guidance which to ...

RAC DRUGS LATEST 2023 ALREADY PASSED (EU) MA Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA National, centralised, mutual recognition, decentralized procedures MAH A legal person or legal entity who must be established in the European Economic Area comprising of 28 member states. What does an MA include? Active substance international non-proprietary name, trade name. SmPC Summary of Product Char...

CCRC Exam (Latest 2024/ 2025 Update) Practice Questions and Verified Answers| 100% Correct| Grade A Q: What does CDER stand for? Answer: Center for Drug Evaluation and Research Q: What does CBER stand for? Answer: Center for Biologics Evaluation and Research Q: What is the central goal of the harmonization effort? Answer: To identify and then reduce differences in technical requirements for drug development among regulatory agencies Q: What organization...

LML4810: Assignment 01 Semester 2: 2022 Unique number: QUESTION 1 Discuss the legal challenges that electronic commerce poses to consumers and businesses, also explain the extent to which the Electronic Communication and Transactions Act of 2002 has addressed these challenges. (15) The following are the challenges posed by e-commerce as noted in the Green paper: taxation; 1 intellectual-property protection; consumer protection domain naming; electronic-payment mechanisms. Eise...

AGB 302 WEEK 5 QUIZ LATEST UPDATE WITH VERIFIED SOLUTIONS When a tourist goes to a bank in a foreign country to convert money into a local currency exchange rate used is the Forward rate spot rate currency swap rate carry trade Spot rate Country X and country Y reach an agreement to boost bilateral trade they agreed to remove all barriers to the trade of goods and services. They however are free to determine their own trade policies with regard to nonmembers which level of economic integrat...

Ammo 67 exam questions and answers 100% pass Types of hazmat transportation land (highway/rail) sea air Define hazmat any material or substance capable of posing an unreasonable risk to health, safety, and property when transported. What training does the HAZMAT Familiarization and Safety in Transportation course provide? applicability and responsibility emergency response general awareness/familiarization security awareness What if the function of a DD Form 626? *Used by the Quality Assuranc...